Evidence map›Paper›PMID 29029033›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2017

Trial Evaluating Ambulatory Therapy of Travelers' Diarrhea (TrEAT TD) Study: A Randomized Controlled Trial Comparing 3 Single-Dose Antibiotic Regimens With Loperamide.

Mark S Riddle, Patrick Connor, Jamie Fraser, Chad K Porter, Brett Swierczewski, Emma J Hutley, Brook Danboise, Mark P Simons, Christine Hulseberg, Tahaniyat Lalani and 3 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01618591 (A Randomized, Double-Blind, Clinical Trial Evaluating Three Single Dose Regimens With Loperamide for Treatment of Ambulatory Watery Travelers' Diarrhea, and Azithromycin With and Without Loperamide for Treatment of Ambulatory Dysentery/Febrile Diarrhea), which is not on this map. Cited by 30 papers.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed
7.4field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01618591 naterminatednot on this map

A Randomized, Double-Blind, Clinical Trial Evaluating Three Single Dose Regimens With Loperamide for Treatment of Ambulatory Watery Travelers' Diarrhea, and Azithromycin With and Without Loperamide for Treatment of Ambulatory Dysentery/Febrile Diarrhea

TypeinterventionalSponsorUniformed Services University of the Health SciencesRan2012 to 2016Enrolled384ConditionsAcute Watery Diarrhea, Dysentery/Febrile DiarrheaArmsSingle dose rifaximin 1650 mg, Single dose azithromycin 500 mg, Single dose levofloxacin 500 mg, Single dose azithromycin 1000 mg plus loperamide, Single dose azithromycin 1000 mg plus placebo
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 57 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Trial
  5. EnteroaggregativeEcoSal Plus · 2025
    Review
  6. ACS omega · 2025
    Article
  7. Article
  8. Article
  9. The Controlled Human Infection Model for Enterotoxigenic Escherichia coli.Current topics in microbiology and immunology · 2024
    Review
  10. Extracellular components in enteroaggregativeFrontiers in cellular and infection microbiology · 2024
    Article
  11. Outbreak of Diarrhea Caused by a NovelOpen forum infectious diseases · 2024
    Article
  12. Article
  13. Molecular Epidemiology ofMicroorganisms · 2022
    Article
  14. Review
  15. Article
  16. Article
  17. Genetic and Virulence Profiles of EnteroaggregativeFrontiers in cellular and infection microbiology · 2020
    Article
  18. Article
  19. Article
  20. Consensus Report on Shigella Controlled Human Infection Model: Conduct of Studies.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2019
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 7 institutions in 5 countries.

Mark S RiddleNaval Medical Research Center, Silver Spring, Maryland.
Patrick ConnorAcademic Department of Military Medicine, Royal Centre for Defence Medicine, Birmingham, United Kingdom.
Jamie FraserInfectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences, Bethesda, Maryland.
Chad K PorterNaval Medical Research Center, Silver Spring, Maryland.
Brett SwierczewskiArmed Forces Research Institute for the Medical Sciences, Bangkok, Thailand.
Emma J HutleyCentre of Defence Pathology, Royal Centre for Defence Medicine, Birmingham, United Kingdom.
Brook DanboiseUS Army Research Unit Kenya, Kericho.
Mark P SimonsNaval Medical Research Unit No. 6, Lima, Peru.
Christine HulsebergUS Army Research Unit Kenya, Kericho.
Tahaniyat LalaniInfectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences, Bethesda, Maryland.
Ramiro L GutierrezNaval Medical Research Center, Silver Spring, Maryland.
David R TribbleInfectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences, Bethesda, Maryland.
TrEAT TD Study Team
Naval Medical Research Command · USHenry M. Jackson Foundation · USRoyal Navy · GBUniformed Services University of the Health Sciences · USUnited States Army Medical Research Directorate - Africa · KEUnited States Naval Medical Research Unit SOUTH · PEArmed Forces Research Institute of Medical Science · TH

Funding

NIAID NIH HHS Y01 AI005072
6 · The paper itself

Abstract

backgroundRecommended treatment for travelers' diarrhea includes the combination of an antibiotic, usually a fluoroquinolone or azithromycin, and loperamide for rapid resolution of symptoms. However, adverse events, postdose nausea with high-dose azithromycin, effectiveness of single-dose rifaximin, and emerging resistance to front-line agents are evidence gaps underlying current recommendations.

methodsA randomized, double-blind trial was conducted in 4 countries (Afghanistan, Djibouti, Kenya, and Honduras) between September 2012 and July 2015. US and UK service members with acute watery diarrhea were randomized and received single-dose azithromycin (500 mg; 106 persons), levofloxacin (500 mg; 111 persons), or rifaximin (1650 mg; 107 persons), in combination with loperamide (labeled dosing). The efficacy outcomes included clinical cure at 24 hours and time to last unformed stool.

resultsClinical cure at 24 hours occurred in 81.4%, 78.3%, and 74.8% of the levofloxacin, azithromycin, and rifaximin arms, respectively. Compared with levofloxacin, azithromycin was not inferior (P = .01). Noninferiority could not be shown with rifaximin (P = .07). At 48 and 72 hours, efficacy among regimens was equivalent (approximately 91% at 48 and 96% at 72 hours). The median time to last unformed stool did not differ between treatment arms (azithromycin, 3.8 hours; levofloxacin, 6.4 hours; rifaximin, 5.6 hours). Treatment failures were uncommon (3.8%, 4.4%, and 1.9% in azithromycin, levofloxacin, and rifaximin arms, respectively) (P = .55). There were no differences between treatment arms with postdose nausea, vomiting, or other adverse events.

conclusionsSingle-dose azithromycin, levofloxacin, and rifaximin with loperamide were comparable for treatment of acute watery diarrhea. CLINICAL

trial registrationNCT01618591.

Indexed as

TravelAcute DiseaseAdultAfghanistanAnti-Bacterial AgentsAzithromycinDiarrheaDjiboutiDouble-Blind MethodDrug Therapy, CombinationEscherichia coliEscherichia coli InfectionsFemaleHondurasHumansKenyaAnti-Bacterial AgentsAzithromycinLevofloxacinLoperamideazithromycinlevofloxacinrandomized control trialrifaximintravelers’ diarrhea

Identifiers

PMID29029033
PMCPMC5848251
OpenAlexW2793521575

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.